Certican

Certican

everolimus

Manufacturer:

Novartis

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Everolimus
Indications/Uses
In combination w/ ciclosporin (for microemulsion) & corticosteroids for the prophylaxis of organ rejection in adults at low to moderate immunological risk receiving an allogeneic renal or cardiac transplant. In combination w/ tacrolimus & corticosteroids for the prophylaxis of organ rejection in patients receiving a hepatic transplant.
Dosage/Direction for Use
Adult Initially 0.75 mg bid administered as soon as possible after general kidney & heart transplantation & 1 mg bid approx 4 wk after hepatic transplantation. Adjust dose at 4- to 5-day intervals based on achieved blood levels, tolerability, response, change in co-medications & clinical situation. Recommended everolimus whole blood trough levels: 3-8 ng/mL.
Administration
May be taken with or without food: Take consistently either always w/ or always w/o meals. Avoid grapefruit juice.
Contraindications
Hypersensitivity to everolimus, sirolimus.
Special Precautions
Hepatic impairment. Monitor patients for skin neoplasms; minimise exposure to UV & sunlight. Increased susceptibility to infections. Established hyperlipidaemia. Monitor renal function. Pregnancy & lactation.
Adverse Reactions
Viral, bacterial & fungal infections, URTI, leucopenia, pericardial effusion, hyperlipidaemia, new onset DM, HTN, pleural effusion, abdominal pain, peripheral oedema, incisional hernia.
Drug Interactions
Ciclosporin, rifampicin, atorvastatin & pravastatin, midazolam, antifungal agents, macrolides, Ca-channel blockers, PIs, St. John's wort, anticonvulsants, grapefruit juice, live vaccines.
MIMS Class
Immunosuppressants
ATC Classification
L04AH02 - everolimus ; Belongs to the class of mammalian target of rapamycin (mTOR) kinase inhibitors. Used as immunosuppressants.
Presentation/Packing
Form
Certican tab 0.25 mg
Packing/Price
6 × 10's
Form
Certican tab 0.5 mg
Packing/Price
6 × 10's
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